2025-522883-34-00招募中4 期
PROTECx - Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 261
- 试验地点
- 11
研究概览
简要总结
• To evaluate the PFS at 12 months and compare to the historical PFS of the KEYNOTE-826 trial.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •for the observation cohort: Persistent, recurrent, or metastatic cervical cancer commencing treatment or currently treated with a pembrolizumab containing regimen.
- •Inclusion criteria for the early discontinuation cohort: • Previous inclusion in the observation cohort • Choice made to stop pembrolizumab for one of the following reasons: o Confirmed complete response if they had received at least 8 cycles of 3- weekly pembrolizumab, including at least 9 weeks beyond a CR (consistent with KEYNOTE-826 criteria) OR o Immune-related toxicity grade ≥ 3 OR o Patient’s preference (e.g. chronic or invalidating grade 1-2 immune-related toxicity) OR o Confirmed partial response if they had received at least 8 cycles of 3- weekly pembrolizumab, including at least 9 weeks beyond a PR (timing consistent with KEYNOTE-826 criteria) • Eligible and willing to discontinue pembrolizumab (with or without discontinuing bevacizumab)
排除标准
- •Malignant other disease other than cervical carcinoma that required active treatment in the past 2 years: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or any carcinoma in situ that have undergone potentially curative therapy are not excluded
- •Any condition, in opinion of the investigator, that may hamper compliance to the study procedures.
- •Insufficient proficiency in written and spoken Dutch to understand the study information, complete Dutch language questionnaires, or provide informed consent will be excluded
研究组 & 干预措施
Avastin 25 mg/ml concentrate for solution for infusion.
Test
干预措施: Avastin 25 mg/ml concentrate for solution for infusion. (Drug)
KEYTRUDA 25 mg/mL concentrate for solution for infusion.
Test
干预措施: KEYTRUDA 25 mg/mL concentrate for solution for infusion. (Drug)
研究者
M. Jalving
Scientific
Universitair Medisch Centrum Groningen
研究点 (11)
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